Class II · Moderate risk Ongoing
chloroproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.
FDA Drug Recalls
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Class II · Moderate risk Ongoing
chloroproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.
Class II · Moderate risk Ongoing
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50…
Reason Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Class II · Moderate risk Ongoing
Ultra Violette
Reason Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Class II · Moderate risk Ongoing
Sulfamethoxazole and Trimethoprim Tablets
Reason Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
Acetaminophen Injection 1000 mg/100 mL
Reason Discoloration
Class II · Moderate risk Ongoing
Carvedilol Tablets USP
Reason CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class III · Low risk Ongoing
Readyprep Pvp
Reason Subpotent drug
Class I · High risk Ongoing
0.9% Sodium Chloride Injection USP
Reason Presence of Particulate Matter.
Class I · High risk Ongoing
Lactated Ringers's Injection USP
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
Sulfamethoxazole and Trimethoprim Tablets
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk Ongoing
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Reason Temperature Abuse
Class II · Moderate risk Ongoing
Tavaborole Topical Solution 5%
Reason Discoloration
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
Theophylline extended-release tablets 400mg
Reason Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II · Moderate risk Ongoing
Metoprolol Tartrate Tablets
Reason CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.